Study:
Phase III MultiCenter Randomized Controlled Study to Assess Efficacy and Safety of ON 01910.Na 72-Hr Continuous IV Infusion in MDS Patients With Excess Blasts Relapsing After or Refractory to or Intolerant to Azacitidine or Decitabine
Rationale:
n/a
Purpose:
The primary objective of this study is to compare overall survival (OS) in patients
receiving ON 01910.Na + best supportive care (BSC) to OS of patients receiving BSC in a
population of patients with myelodysplastic syndrome (MDS) with excess blasts (5% to 30%
bone marrow blasts) who have failed azacitidine or decitabine treatment. This patient
population has no available therapy and a short life expectancy (approximately 4 months).
The high level of bone marrow activity of ON 01910.Na documented in Phase 1 and 2 studies
has the potential to delay substantially the transition of MDS to Acute Myeloid
Leukemia(AML), a very significant and severe complication, which shortens survival of these
MDS patients.
Study Status: Recruiting
Recruiting:
n/a
| Condition |
Intervention |
Phase |
Myelodysplastic Syndromes
MDS
RAEB
Chronic Myelomonocytic Leukemia |
Drug: ON 01910.Na |
Phase 3 |
Verified by
Onconova Therapeutics, Inc.
May, 2012
Sponsored by: Onconova Therapeutics, Inc.
Information provided by: Onconova Therapeutics, Inc.
ClinicalTrials.gov identifier: NCT01241500
Study Type: Interventional
Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Cleveland Clinic
Cleveland, Ohio 44195
United States
Francois E. Wilhelm, MD, PhD., Study Director
